Intensive Care Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia.
Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
Trials. 2023 Jul 30;24(1):485. doi: 10.1186/s13063-023-07507-6.
Protein intake is recommended in critically ill patients to mitigate the negative effects of critical illness-induced catabolism and muscle wasting. However, the optimal dose of enteral protein remains unknown. We hypothesize that supplemental enteral protein (1.2 g/kg/day) added to standard enteral nutrition formula to achieve high amount of enteral protein (range 2-2.4 g/kg/day) given from ICU day 5 until ICU discharge or ICU day 90 as compared to no supplemental enteral protein to achieve moderate amount enteral protein (0.8-1.2 g/kg/day) would reduce all-cause 90-day mortality in adult critically ill mechanically ventilated patients.
The REPLENISH (Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients) trial is an open-label, multicenter randomized clinical trial. Patients will be randomized to the supplemental protein group or the control group. Patients in both groups will receive the primary enteral formula as per the treating team, which includes a maximum protein 1.2 g/kg/day. The supplemental protein group will receive, in addition, supplemental protein at 1.2 g/kg/day starting the fifth ICU day. The control group will receive the primary formula without supplemental protein. The primary outcome is 90-day all-cause mortality. Other outcomes include functional and quality of life assessments at 90 days. The trial will enroll 2502 patients.
The study has been initiated in September 2021. Interim analysis is planned at one third and two thirds of the target sample size. The study is expected to be completed by the end of 2025.
ClinicalTrials.gov Identifier: NCT04475666 . Registered on July 17, 2020.
在危重症患者中推荐蛋白质摄入，以减轻危重病引起的分解代谢和肌肉消耗的负面影响。然而，肠内蛋白质的最佳剂量仍不清楚。我们假设与不给予补充肠内蛋白质相比，在 ICU 第 5 天至 ICU 出院或 ICU 第 90 天期间，通过补充肠内营养配方给予 1.2 g/kg/天的额外肠内蛋白质（达到高蛋白质摄入量，范围为 2-2.4 g/kg/天），以达到中等量的肠内蛋白质（0.8-1.2 g/kg/天），可降低成年危重症机械通气患者的全因 90 天死亡率。
REPLENISH（逐步通过肠内营养补充蛋白质在危重症患者中的研究）试验是一项开放标签、多中心随机临床试验。患者将被随机分配到补充蛋白质组或对照组。两组患者均将按照治疗团队接受主要肠内配方，其中包括最大蛋白 1.2 g/kg/天。补充蛋白质组将从 ICU 第 5 天开始额外给予 1.2 g/kg/天的补充蛋白质。对照组将在没有补充蛋白质的情况下接受主要配方。主要结局是 90 天全因死亡率。其他结局包括 90 天的功能和生活质量评估。该试验将纳入 2502 例患者。
该研究已于 2021 年 9 月开始。计划在三分之一和三分之二的目标样本量时进行中期分析。预计该研究将于 2025 年底完成。
ClinicalTrials.gov 标识符：NCT04475666。于 2020 年 7 月 17 日注册。
